510(k) · Cleared
ClearedBiWaze Cough
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abmrc, LLC · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Mar 27, 2020 as substantially equivalent to K121955 (Respironics, Inc., 2012) after a 254-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Mar 27, 2020
- Review
- 254 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002598 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002598 Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model…J. H. Emerson Co. · 2000
- 2 generations backK072292 Negavent Plus Pegaso Cough, Model: DA-3 PlusDima Italia Srl · 2008
- 1 generation backK121955 Coughassist T70 DeviceRespironics, Inc. · 2012
- This deviceK191912 BiWaze CoughAbmrc, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000… | J. H. Emerson Co. | 2000 | — |
| −2 | K072292 | Negavent Plus Pegaso Cough, Model: DA-3 Plus | Dima Italia Srl | 2008 | — |
| −1 | K121955 | Coughassist T70 Device | Respironics, Inc. | 2012 | — |
| 0 (this device) | K191912 | BiWaze Cough | Abmrc, LLC | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHJ device
- #1 K260604 BiWaze Clear Systemscore 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K121955.
How does its category compare?
All NHJ devicesNHJ Device, Positive Pressure Breathing, Intermittent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NHJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHJ
190in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHJ
11so far in 2026, the most since 2007
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · NHJ
35in 2025
MAUDE reports naming product code NHJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 16 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 207 | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 3 | 190 | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 1 | — | 1 (1) | 40 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 2 | — | 11 (4) | — |
What is it indicated for?
This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough exspiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or at home. For use on adult patients and pediatric patients 3 years old and up.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191912: BiWaze Cough.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191912
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026